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Medical Play for Dental Anxiety

N/A
Recruiting
Led By Chaitanya P Puranik, BDS,MS,PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-intervention), post-intervention (immediately after dental visit)
Awards & highlights

Study Summary

This trial will use a medical play intervention with the aim of improving behaviors and cooperation of neurotypical patients during dental visits.

Who is the study for?
This trial is for neurotypical children aged 5-10 who have shown significant dental anxiety or aversion during past visits to the Children's Hospital Colorado Dental Center. They must be patients of record at this center and accompanied by their legal guardian.Check my eligibility
What is being tested?
The study tests if 'medical play' before a dental exam can help improve cooperation and reduce anxiety in children, compared to routine play or no special preparation. It also assesses perceptions of behavior from providers, caregivers, and the patients themselves.See study design
What are the potential side effects?
Since this trial involves non-invasive methods like medical play, there are no direct physical side effects expected. However, emotional responses will vary among participants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-intervention), post-intervention (immediately after dental visit)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-intervention), post-intervention (immediately after dental visit) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Behavior as measured by Frankl score
Completion of Components of dental examination
Secondary outcome measures
Patient perception before and after dental visit
Post-intervention parental perceptions about their child's behavior
Pre-intervention parental perceptions about their child's behavior

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Medical Play InterventionActive Control1 Intervention
This group of participants will be engaged in medical play before the dental exam visit.
Group II: Routine Play InterventionPlacebo Group1 Intervention
This group of participants be engaged in routine play (coloring exercise) before the dental exam visit.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,734 Previous Clinical Trials
2,148,783 Total Patients Enrolled
Chaitanya P Puranik, BDS,MS,PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus

Media Library

Medical Play Clinical Trial Eligibility Overview. Trial Name: NCT05571423 — N/A
Dental Anxiety Research Study Groups: Medical Play Intervention, Routine Play Intervention
Dental Anxiety Clinical Trial 2023: Medical Play Highlights & Side Effects. Trial Name: NCT05571423 — N/A
Medical Play 2023 Treatment Timeline for Medical Study. Trial Name: NCT05571423 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research program include individuals of thirty years and older as participants?

"The age range for this clinical trial is between 5 and 10 years old. Furthermore, there are 8 different trials open to participants younger than 18 while the elderly (over 65) have access to a further 5 studies."

Answered by AI

Are there any vacancies for volunteers in this experiment?

"According to the data on clinicaltrials.gov, this medical study is no longer actively seeking patients and was last updated October 5th 2022. Despite that, 13 other trials are still open for enrollment at present."

Answered by AI

What criteria must one meet to be eligible for participation in this study?

"This anxiety-related trial is enrolling a cohort of 100 children, aged 5 to 10. All participants must have previously been classified as Frankl 1 or 2 according to their electronic dental record (Epic) and be neurotypical with an existing connection to the Children's Hospital Colorado Dental Center. Furthermore, for eligibility all applicants should have legal guardians who can provide consent on their behalf."

Answered by AI
~47 spots leftby Oct 2025